Evidence map›Paper›PMID 31628848›Full record

Trial reportThe Journal of infectious diseases2020

Production and Clinical Evaluation of Norwalk GI.1 Virus Lot 001-09NV in Norovirus Vaccine Development.

Roberto Mateo, Lisa C Lindesmith, Shaily J Garg, Keith Gottlieb, Karen Lin, Sara Said, Juan S Leon, Amy C Sims, David J Weber, Ralph S Baric and 2 more

Abstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of infectious diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Review
  2. The unfulfilled potential of mucosal immunization.The Journal of allergy and clinical immunology · 2022
    Review
  3. Review
  4. Article
  5. Journal of structural biology: X · 2020
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Roberto MateoVaxart, Inc., South San Francisco, California, USA.
Lisa C LindesmithDepartment of Epidemiology, University of North Carolina, Chapel Hill, North Carolina, USA.
Shaily J GargVaxart, Inc., South San Francisco, California, USA.
Keith GottliebVaxart, Inc., South San Francisco, California, USA.
Karen LinVaxart, Inc., South San Francisco, California, USA.
Sara SaidVaxart, Inc., South San Francisco, California, USA.
Juan S LeonHubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.
Amy C SimsDepartment of Epidemiology, University of North Carolina, Chapel Hill, North Carolina, USA.
David J WeberDivision of Infectious Diseases, University of North Carolina, Chapel Hill, North Carolina, USA.
Ralph S BaricDepartment of Epidemiology, University of North Carolina, Chapel Hill, North Carolina, USA.
Sean N TuckerVaxart, Inc., South San Francisco, California, USA.
David N TaylorVaxart, Inc., South San Francisco, California, USA.

Funding

Translational CoreU19AI109761 · NIAID · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI RELMAN, DAVID A. · 2014 to 2018
$32.6M
REVERSE GENETICS WITH A CORONAVIRUS INFECTIOUS CONSTRUCTR01GM063228 · NIGMS · UNIVERSITY OF NORTH CAROLINA CHAPEL HILL · PI BARIC, RALPH S · 2001 to 2004
$1.0M
NIAID NIH HHS U19 AI109761NIGMS NIH HHS R01 GM063228Wellcome Trust 203268/Z/16/Z
6 · The paper itself

Abstract

backgroundHuman noroviruses (HuNoV) are the leading cause of gastroenteritis. No vaccine is currently available to prevent norovirus illness or infection. Safe, infectious challenge strains are needed to assess vaccine efficacy in the controlled human infection model (CHIM).

methodsA stock of HuNoV strain Norwalk virus ([NV] GI.1) was prepared. Healthy, genetically susceptible adults were inoculated with NV Lot 001-09NV and monitored for infection, gastroenteritis symptoms, and immune responses.

resultsLot 001-09NV induced gastroenteritis in 9 (56%) and infection in 11 (69%) of 16 genetically susceptible subjects. All infected subjects developed strong immune responses to GI.1 with a 30-fold (geometric mean titer) increase in blocking titers (BT50) and a 161-fold increase in GI.1-specific immunoglobulin (Ig)G titers when compared with baseline. GI.1-specific cellular responses in peripheral blood were observed 9 days postchallenge with an average of 3253 IgA and 1227 IgG antibody-secreting cells per million peripheral blood mononuclear cells.

conclusionsGI.1 Lot 001-09NV appears to be similar in virulence to previous passages of NV strain 8fIIa. The safety profile, attack rate, and duration of illness make GI.1 Lot 001-09NV a useful challenge strain for future vaccine studies aimed at establishing immune correlates.

Indexed as

AdolescentAdultCaliciviridae InfectionsFemaleGastroenteritisHumansMaleMiddle AgedNorwalk virusViral VaccinesYoung AdultViral Vaccinesantibody-secreting cellsblockade antibodycontrolled human infection modelhuman challenge studyhuman norovirus

Identifiers

PMID31628848
PMCPMC7050988

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.